- Four candidates planned to be in clinical development in 2024 with interim data from two studies anticipated by year end
- Clinical development timelines accelerated for ABI-5366; now anticipating interim data from Phase 1a available in 3Q2024, initiation of Phase 1b in individuals with recurrent genital herpes by end of 2024 and interim Phase 1b data available in 1H2025
- Gilead Sciences, Inc. partnership supports advancement and strengthening of antiviral pipeline targeting serious viral diseases
“Our progress in 2023 demonstrated our capacity to drive our expanded antiviral pipeline forward and our commitment to individuals suffering from life-impacting viral diseases,” said
Fourth Quarter 2023 and Recent Highlights
- Entered a long-term partnership with Gilead to advance discovery and development of novel antiviral therapies
- Strengthened the leadership team with the naming of
Anuj Gaggar , MD, PhD, as chief medical officer - Filed a clinical trial application for ABI-5366 to support initiation of Phase 1a/1b clinical studies
Anticipated Milestones and Events
By mid-year 2024:
- ABI-5366, a long-acting herpes simplex virus (HSV) helicase-primase inhibitor targeting recurrent genital herpes, is expected to enter a Phase 1a/1b study
- ABI-4334, a next-generation, highly potent capsid assembly modulator, is anticipated to enter a Phase 1b study in individuals with chronic hepatitis B virus infection
Q3 2024:
- Interim clinical data from the ABI-5366 Phase 1a study portion expected to be available
By the end of 2024:
- Interim clinical data from the ABI-4334 Phase 1b study expected to be available
- The Phase 1b portion of the ABI-5366 study, in individuals with recurrent genital herpes, is anticipated to be underway
- Two additional candidates are anticipated to enter the clinic:
- ABI-1179, a long-acting HSV helicase-primase inhibitor contributed by Gilead under the collaboration between Assembly Bio and Gilead
- ABI-6250, a small molecule orally-bioavailable hepatitis delta virus entry inhibitor
First half 2025:
- Interim clinical data from the Phase 1b portion of the ABI-5366 study expected to be available
Fourth Quarter 2023 and Year End Financial Results
- Cash, cash equivalents and marketable securities were
$130.2 million as ofDecember 31, 2023 , compared to$46.2 million as ofSeptember 30, 2023 , and$91.6 million as of the year endedDecember 31, 2022 . The company’s cash position is projected to fund operations into the second half of 2025. - Revenues from collaborative research were
$7.2 million for the year endedDecember 31, 2023 . There was no revenue recognized for the same period in 2022. Revenue for the year endedDecember 31, 2023 , consists of$4.4 million recognized under the collaboration with Gilead and the remaining deferred revenue balance of$2.7 million under the collaboration agreement with BeiGene following Assembly Bio’s decision to discontinue further development of ABI-H3733 in conjunction with entering into the Gilead collaboration, following the previous prioritization of ABI-4334 over ABI-H3733. - Research and development expenses were
$48.9 million for the year endedDecember 31, 2023 , compared to$70.0 million in 2022. The decrease is due to completion of the clinical trials for ABI-H3733 and ABI-4334, discontinued development of vebicorvir and ABI-H2158, and decreases in employee and contractor-related expenses. - General and administrative expenses were
$22.9 million for the year endedDecember 31, 2023 , compared to$24.1 million in 2022. The decrease is due to overall cost-saving initiatives. - Net loss attributable to common stockholders was
$61.2 million , or$13.38 per basic and diluted share, for the year endedDecember 31, 2023 , compared to$93.1 million , or$23.08 per basic and diluted share in 2022.
The investigational products and investigational product candidates referenced here have not been approved anywhere globally, and their safety and efficacy have not been established.
About Assembly Biosciences
Forward-Looking Statements
The information in this press release contains forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to materially differ. These risks and uncertainties include: Assembly Bio’s ability to realize the potential benefits of its collaboration with Gilead Sciences, Inc., including all financial aspects of the collaboration and equity investments; Assembly Bio’s ability to initiate and complete clinical studies involving its therapeutic product candidates, including studies contemplated by Assembly Bio’s collaboration with Gilead, in the currently anticipated timeframes or at all; safety and efficacy data from clinical or nonclinical studies may not warrant further development of Assembly Bio’s product candidates; clinical and nonclinical data presented at conferences may not differentiate Assembly Bio’s product candidates from other companies’ candidates; results of nonclinical studies may not be representative of disease behavior in a clinical setting and may not be predictive of the outcomes of clinical studies; and other risks identified from time to time in Assembly Bio’s reports filed with the
Contacts
Investor and Corporate:
Shannon Ryan
SVP, Investor Relations, Corporate Affairs and Alliance Management
(415) 738-2992
investor_relations@assemblybio.com
Media:
Sam Brown Inc.
Hannah Hurdle
(805) 338-4752
ASMBMedia@sambrown.com
CONSOLIDATED BALANCE SHEETS | ||||||||
(In thousands except for share amounts and par value) | ||||||||
As of | ||||||||
2023 | 2022 | |||||||
ASSETS | ||||||||
Current assets | ||||||||
Cash and cash equivalents | $ | 19,841 | $ | 52,418 | ||||
Marketable securities | 110,406 | 39,192 | ||||||
Accounts receivable from collaboration | 43 | 944 | ||||||
Prepaid expenses and other current assets | 3,497 | 4,413 | ||||||
Total current assets | 133,787 | 96,967 | ||||||
Property and equipment, net | 385 | 743 | ||||||
Operating lease right-of-use assets | 2,339 | 3,195 | ||||||
Other assets | 312 | 889 | ||||||
Total assets | $ | 136,823 | $ | 101,794 | ||||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
Current liabilities | ||||||||
Accounts payable | $ | 461 | $ | 2,493 | ||||
Accrued research and development expenses | 885 | 3,122 | ||||||
Other accrued expenses | 5,744 | 7,317 | ||||||
Deferred revenue - short-term ( | 30,915 | — | ||||||
Operating lease liabilities - short-term | 1,220 | 3,364 | ||||||
Total current liabilities | 39,225 | 16,296 | ||||||
Deferred revenue - long-term ( | 55,379 | 2,733 | ||||||
Operating lease liabilities - long-term | 1,122 | 101 | ||||||
Total liabilities | 95,726 | 19,130 | ||||||
Commitments and contingencies | ||||||||
Stockholders' equity | ||||||||
Preferred stock, | — | — | ||||||
Common stock, | 5 | 4 | ||||||
Additional paid-in capital | 826,921 | 807,983 | ||||||
Accumulated other comprehensive loss | (81 | ) | (803 | ) | ||||
Accumulated deficit | (785,748 | ) | (724,520 | ) | ||||
Total stockholders' equity | 41,097 | 82,664 | ||||||
Total liabilities and stockholders' equity | $ | 136,823 | $ | 101,794 | ||||
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | ||||||||
(In thousands except for share and per share amounts) | ||||||||
Year Ended | ||||||||
2023 | 2022 | |||||||
Collaboration revenue ( | $ | 7,163 | $ | — | ||||
Operating expenses | ||||||||
Research and development | 48,900 | 69,980 | ||||||
General and administrative | 22,909 | 24,134 | ||||||
Total operating expenses | 71,809 | 94,114 | ||||||
Loss from operations | (64,646 | ) | (94,114 | ) | ||||
Other income | ||||||||
Interest and other income, net | 3,451 | 1,022 | ||||||
Total other income | 3,451 | 1,022 | ||||||
Loss before income taxes | (61,195 | ) | (93,092 | ) | ||||
Income tax expense | (33 | ) | — | |||||
Net loss | $ | (61,228 | ) | $ | (93,092 | ) | ||
Other comprehensive loss | ||||||||
Unrealized gain (loss) on marketable securities | 722 | (384 | ) | |||||
Comprehensive loss | $ | (60,506 | ) | $ | (93,476 | ) | ||
Net loss per share, basic and diluted | $ | (13.38 | ) | $ | (23.08 | ) | ||
Weighted average common shares outstanding, basic and diluted | 4,577,371 | 4,034,105 | ||||||
Source:
2024 GlobeNewswire, Inc., source